| Coverage Policy Manual | |
| Policy #: | 1997011 |
| Category: | Surgery |
| Initiated: | May 1993 |
| Last Review: | November 2023 |
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| Discectomy: Percutaneous and Percutaneous Endoscopic, Manual, Automated or Laser | |
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| Description: |
Back pain or radiculopathy related to herniated discs is an extremely common condition and a frequent cause of chronic disability. Although many cases of acute low back pain and radiculopathy will resolve with conservative care, surgical decompression is often considered when the pain is unimproved after several months and is clearly neuropathic in origin, resulting from irritation of the nerve roots. Open surgical treatment typically consists of discectomy in which the extruding disc material is excised. When performed with an operating microscope, the procedure is known as microdiscectomy.
Minimally invasive options have also been researched, in which some portion of the disc is removed or ablated, although these techniques are not precisely targeted at the offending extruding disc material. Ablative techniques include laser discectomy (addressed in this policy) and radiofrequency decompression (see Medical Coverage Policy 2001012). Intradiscal electrothermal annuloplasty is another minimally invasive approach to low back pain. In this technique, radiofrequency energy is used to treat the surrounding disc annulus (see Medical Coverage Policy 1999016).
Herein we address automated percutaneous and endoscopic discectomy, in which the disc decompression is accomplished by the physical removal of disc material rather than its ablation. Traditionally, discectomy was performed manually through an open incision, using cutting forceps to remove nuclear material from within the disc annulus. This technique was modified by automated devices that involve placement of a probe within the intervertebral disc and aspiration of disc material using a suction cutting device. Endoscopic techniques may be intradiscal or may involve extraction of noncontained and sequestered disc fragments from inside the spinal canal using an interlaminar or transforaminal approach. Following insertion of the endoscope, decompression is performed under visual control.
Regulatory Status
The Dekompressor® Percutaneous Discectomy Probe (Stryker), Herniatome Percutaneous Discectomy Device (Gallini Medical Devices), and the Nucleotome® (Clarus Medical) are examples of percutaneous discectomy devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA indication for these products is for “aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.” FDA product code: HRX.
A variety of endoscopes and associated surgical instruments have also been cleared for marketing by FDA through the 510(k) process.
A number of laser devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for incision, excision, resection, ablation, vaporization, and coagulation of tissue. Intended uses described in FDA summaries include a wide variety of procedures, including percutaneous discectomy. Trimedyne Inc. received 510(k) clearance in 2002 for the Trimedyne® Holmium Laser System Holmium:Yttrium, Aluminum Garnet (Holmium:YAG), in 2007 RevoLix Duo™ Laser System, and in 2009 Quanta System LITHO Laser System. All were cleared, based on equivalence with predicate devices for percutaneous laser disc decompression/discectomy, including foraminoplasty, percutaneous cervical disc decompression/discectomy, and percutaneous thoracic disc decompression/discectomy. The summary for the Trimedyne® system states that indications for cervical and thoracic decompression/discectomy include uncomplicated ruptured or herniated discs, sensory changes, imaging consistent with findings, and symptoms unresponsive to 12 weeks of conservative treatment. Indications for treatment of cervical discs also include positive nerve conduction studies. FDA product code: GEX.
Coding
CPT code 62287 specifically describes a percutaneous decompression procedure of the lumbar spine. This code is specifically limited to the lumbar region. Although most percutaneous discectomies are performed on lumbar vertebrae, Food and Drug Administration labeling of the Stryker Dekompressor Percutaneous Discectomy Probe and the Nucleotome includes the thoracic and cervical vertebrae.
Effective in 2017, there is a specific CPT code for endoscopic decompression:
62380 Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, I interspace, lumbar.
Percutaneous discectomy is also a component of the following CPT codes:
0274T Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (eg, fluoroscopic, CT), single or multiple levels, unilateral or bilateral; cervical or thoracic
0275T lumbar.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous discectomy, manual, automated or by laser, in the lumbar, thoracic, or cervical spine does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, percutaneous discectomy, manual, automated or by laser, in the lumbar, thoracic, or cervical spine is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Endoscopic discectomy in the lumbar, thoracic, or cervical spine does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, endoscopic discectomy in the lumbar, thoracic, or cervical spine is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
The methodology of evidence-based medicine in general has grown in sophistication. Specifically, it is recognized that that randomized clinical trials are extremely important to assess treatments of painful conditions and low back pain in particular, due both to the expected placebo effect, the subjective nature of pain assessment in general, and also the variable natural history of low back pain that often responds to conservative care.
A literature search for the period of 1990 to February 2005 with a specific focus on controlled clinical trials comparing percutaneous discectomy to either open discectomy or conservative therapy. The literature search identified a large number of case series, but only 5 controlled trials, 4 of which were reviewed in a 2000 Cochrane report (Gibson, 2003). The Cochrane review concluded, “Three trials of percutaneous discectomy provided moderate evidence that it produces poorer clinical outcomes than standard discectomy or chymopapain.” For example, Chatterjee reported on the results of a study that randomized 71 patients with lumbar disc herniation to undergo either percutaneous discectomy or lumbar microdiscectomy (Chatterjee, 1995). A successful outcome was reported in only 29% of those undergoing percutaneous discectomy compared to 80% in the microdiscectomy group. The trial was halted early due to this inferior outcome. In a 1993 randomized study, Revel and colleagues compared the outcomes of percutaneous discectomy to chymopapain injection in 141 patients with disk herniation and sciatica (Revel, 1993). Treatment was considered successful in 61% of patients in the chymopapain group compared to 44% in the percutaneous discectomy group. Another trial cited in the Cochrane review, Mayer et. al., is not applicable since the technique used modified forceps in addition to a suction probe (Mayer, 1993). Finally, the last trial cited in the Cochrane review, Hermantin et. al., provided insufficient data to allow detailed analysis of results (Hermantin, 1999).
The only additional controlled study published since the 2000 Cochrane review was the results of the LAPDOG study, a randomized trial designed to compare percutaneous and open discectomy in patients with lumbar disc herniation (Haines, 2002). This trial was designed to recruit 330 patients, but only was able to recruit 36 patients, for reasons that were not readily apparent to the authors. Of the evaluable 27 patients, 41% of the percutaneous discectomy patients and 40% of the conventional discectomy patients were assessed as having successful outcomes at 6 months. The authors concluded that this trial was unable to enroll sufficient numbers of patients to reach a definitive conclusion. The authors state, “It is difficult to understand the remarkable persistence of percutaneous discectomy in the face of a virtually complete lack of scientific support for its effectiveness in treated lumbar disc herniation.”
All of the trials reviewed above focused on lumbar disc herniation. There were no clinical trials of percutaneous discectomy of cervical or thoracic disc herniation.
Summary
Based on the above, percutaneous discectomy remains unproven, and does not meet member benefit certificate Primary Coverage Criteria for effectiveness.
2009 Update
A search of the MEDLINE database did not identify any additional controlled trials. Gibson and Waddel published an updated Cochrane review of surgical interventions for lumbar disc prolapse, concluding that there is insufficient evidence on percutaneous discectomy techniques to draw firm conclusions. A task force of the American Society of Interventional Pain Physicians reports that percutaneous disc decompression remains controversial; although all observational studies were positive, the evidence from 4 of 4 randomized published studies was negative (Boswell et al, 2007). Questions also remain about the appropriate patient selection criteria (particularly related to the size and migration of the disc herniation) for this procedure. (Gibson, 2007).
Freeman and Mehdian assessed the current evidence for three minimally invasive techniques used to treat discogenic low back pain and radicular pain: electrothermal therapy (IDET), percutaneous discectomy, and Nucleoplasty (Freeman, 2008). They report that trials of automated percutaneous discectomy suggest that clinical outcomes are at best fair and often worse when compared with microdiscectomy.
Two systematic reviews published in 2009 were identified, each analyzing the literature for a different device. Hirsch and colleagues reviewed 4 randomized controlled trials (RCTs) and 76 observational studies in their analysis of studies in which the Nucleotome was used (Hirsch, 2009). In two of the RCTs, the comparator was chemonucleolysis. The first, Revel et al, was reviewed in a previous update. The second of these RCTs did not meet Cochrane review criteria for randomized controlled trials. The other two RCTs compared automated percutaneous discectomy with microdiscectomy and also failed to meet study quality criteria. Singh et al. Performed a systematic analysis of studies in which the Dekompressor device was used (Singh, 2009). The authors identified no RCTs.
Goupille et al reviewed the literature on laser disc decompression and concluded that “although the concept of laser disc nucleotomy is appealing, this treatment cannot be considered validated for disc herniation-associated radiculopathy resistant to medical treatment.” They cite the lack of consensus regarding technique, the questionable methodology and conclusions of published studies, and the absence of a controlled study in their discussion (Goupille, 2007). One recent study of laser disc decompression was identified. Ishiwata et al investigated the clinical results of their magnetic resonance-guided percutaneous laser disc decompression practice with reference to the site of the needle tip in the disc. They divided the disc on axial image into 4 quadrants and 3 concentric zones and evaluated clinical results by MacNab’s criteria in each subdivided area 6 months after the procedure. The authors report an overall success rate of 68.8% in their series of 32 patients, and conclude that targeting certain zones seems to result in better outcomes (Ishiwata, 2007).
The absence of new evidence from randomized controlled trials prevents reconsideration of the policy statement.
2012 Update
A search of the MEDLINE database was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement.
2015 Update
This policy is being reviewed with a literature search conducted using the MEDLINE database through March 2015. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
Automated Percutaneous Discectomy
A 2013 review of the evidence from the American Society of Interventional Pain Physicians noted that “even though Dekompressor may be considered a new interventional modality, the early studies were published approximately 8 years ago. Consequently, one would expect that the technique’s continued use would be supported by more recent, high quality evaluations” (Manchikanti, 2013).
Endoscopic Discectomy
A 2014 Cochrane review evaluated 11 studies of minimally invasive discectomy compared with microdiscectomy/open discectomy (Rasouli, 2014). Included in the review were 8 RCTs or quasi-randomized controlled trials that evaluated percutaneous endoscopic lumbar discectomy. Also included were 3 studies on transmuscular tubular microdiscectomy and automated percutaneous lumbar discectomy. Seven of the studies reviewed had a high risk of bias. The review concluded that minimally invasive discectomy may be inferior in terms of relief of leg pain, low back pain, and re-hospitalization; however, differences in pain relief appeared to be small and may not be clinically important. In addition, potential advantages of minimally invasive discectomy are a lower risk of surgical site infection and shorter hospital stay.
Eight-year follow-up from a quasi-randomized controlled trial of endoscopic lumbar discectomy versus open discectomy was reported by Hussein et al in 2014 (Hussein, 2014). The study included 185 patients with a large uncontained lumbar disc herniation. Operative time was similar in the 2 groups. After surgery, the mean length of stay was 10.4 h for the endoscopic group and 82.38 h (3.5 days, p< 0.05) for the open group. The mean time to return to work/normal activities after endoscopic surgery (8.5 days) was significantly shorter than after open surgery (31.4 days, p< 0.05). There was a similar percentage of adverse events in the 2 groups and 8.1% of patients in each group required reoperation during the follow-up. Leg pain, back pain, and ODI scores (1.05, 1.43, 21.5%, respectively) remained improved over the 8 years of follow-up in the endoscopic group, while the open group had a deterioration of back pain (7.53) and ODI scores (59.6%) over the same time period.
The largest and longest follow-up to date is from an observational study from Choi et al, who reported their experience with 10,228 patients at their institution who had undergone percutaneous endoscopic lumbar discectomy over a 12 year period (Choi, 2015). They found that 4.3% of cases required reoperation in the first 6 weeks due to incomplete removal of herniated discs (2.8%), recurrence (0.8%), persistent pain (0.4%) and approach-related pain (0.2%).
Summary
Automated percutaneous discectomy involves placement of a probe within the intervertebral disc under image guidance with aspiration of disc material using a suction cutting device. There is insufficient evidence obtained from well-designed and executed randomized controlled trials (RCTs) to evaluate the impact of automated percutaneous discectomy on net health outcome. In addition, evidence from small RCTs does not support the use of these procedures.
Endoscopic discectomy involves the percutaneous placement of a working channel under image guidance, followed by visualization of the working space and instruments through an endoscope. The evidence consists of a number of RCTs. Most of these trials were conducted at a single center in Germany, and the comparison groups were not the same. The trials in the lumbar spine compared endoscopic discectomy with conventional microdiscectomy, and trials in the cervical spine compared procedures with anterior cervical discectomy and fusion. While the trials from Germany report outcomes
that are at least as good as traditional approaches using either a laparoscopic transforaminal or interlaminar approach to the lumbar spine, a large RCT from Italy reports a trend toward increased complications and reherniations with an interlaminar approach. There are few reports from the United States. The trials by Ruetten et al are the only reports identified of endoscopic discectomy in the cervical spine. At this time, evidence is considered insufficient to evaluate health outcomes from endoscopic discectomy in U.S. centers.
2016 Update
A literature search conducted through March 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2016 meta-analysis identified 9 RCTs with 1,092 patients that compared endoscopic versus open discectomy for lumbar disc herniation.18 Compared with open discectomy, endoscopic discectomy was found to result in similar clinical outcomes with significantly greater patient satisfaction, lower intraoperative blood loss, and shorter length of hospital stay.
2017 Update
A literature review conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.
2017 Update
A literature search conducted using the MEDLINE database through October 2017 did not reveal any new information that would prompt a change in the coverage statement.
One RCT published in 2016 was identified comparing CPM (n=20) with PT (n=21) for the treatment of adhesive capsulitis in patients with diabetes (Ekim, 2016). CPM or PT was provided for 1 hour a day (5 d/wk) for 4 weeks. All patients received electrotherapy and, after the 4-week initial treatment phase, were instructed to continue with an 8-week at-home exercise program. Outcome measures were pain (at rest, in motion, at night) and ROM (active and passive). Pain decreased significantly in both treatment groups, though patients in the CPM group reported a larger improvement in pain scores than those in the PT group. ROM improved significantly in both treatment groups as well. Patients in the CPM group reported larger improvements in abduction and flexion measures than patients in the CPM group, while external and internal rotation improvements were similar across groups.
2018 Update
A literature search was conducted through October 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Yu et al compared percutaneous transforaminal endoscopic discectomy to MED in a systematic review of 8 comparative studies with a total of 805 patients (Yu, 2019). Hospital stay, time in bed, and incision length were shorter with PTED, but there were not differences between the interventions in surgical time or intraoperative blood loss. VAS back and leg pain scores were similar between groups at most time points, with the exception of lower leg pain VAS score at 1 week in the PTED group.
Wang et al compared percutaneous transforaminal endoscopic discectomy to MED in a RCT of 90 patients with lumbar disc herniation at a single center in China (Wang, 2019). Patients in the percutaneous transforaminal endoscopic discectomy group had significantly better surgical and immediate postoperative outcomes (length of surgical incision, bleeding, postoperative bedridden time and hospital stay), while the MED group had shorter surgical time. Both groups improved from baseline on low back pain VAS scores at 3 days, 3 months, and 6 months. Both groups also improved on ODI scores and there were no differences between groups postoperatively or up to 6 months after surgery.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Several systematic reviews of percutaneous endoscopic discectomy versus other discectomy procedures have been done including a recently published one by Xu et al. Participants include patients with single-level lumbar disc herniation who underwent PELD (percutaneous endoscopic lumbar discectomy) or MED (microendoscopic discectomy) for treatment (Xu, 2020). 984 people participated (468 in the PELD group and 516 in the MED group). Study consisted of 9 trials (1 prospective RCT and 8 retrospective nonrandomized comparative studies) between the years of 2012-2018 with follow-up in 1 to more than 6 years. No differences were found in leg pain visual analog scale score before surgery or at any follow-up time after surgery. PELD obtained better outcomes in low back pain visual analog scale score and Oswestry Disability Index score with excellent and good ratio after 24 months postoperatively compared with MED. No difference was found within 24 months postoperatively. No significant differences were found in complication, recurrence, and reoperation rates within and after 2 years postoperatively.
Results from these systematic reviews including the one by Xu et al were fairly consistent with a significantly reduced length of hospitalization observed with endoscopic discectomy and sometimes significant improvements in VAS or ODI, but only at specific time points. Overall, no consistently significant improvement in VAS, ODI, total complication rate, reoperation, or recurrence was observed with endoscopic discectomy versus other interventions. Authors of the systematic reviews noted multiple limitations including the innate flaws of included studies (ie, observational designs, a limited number of studies meeting criteria for inclusion, small sample sizes, lack of allocation concealment and blinding), different methodologies contributing to heterogeneity in analyses, loss of usable and sufficient data resulting in difficulty performing accurate analysis of outcomes, and that a majority of the more recently completed studies were completed in China, which may affect the generalizability of the results to other populations.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Gadjradj et al conducted a RCT in the Netherlands at 4 sites between February 2016 to April 2019 (Gadjradj, 2022). Participants included patients with sciatica caused by lumbar disc herniation. Purpose was to assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. The study consisted of 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED before the trial. PTED (n=179) compared with open microdiscectomy (n=309). The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. At 12 months, patients who were randomized to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomized to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95%confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilization was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favor of PTED. Within one year, nine (5%) in the PTED group compared with14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favorable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.
Ran et al conducted a RCT in China at 1 site between August 2016 to February 2020 (Ran, 2021). Participants included patients with highly migrated lumbar disc herniation. Interventions included PELD with computerized tomography navigation vs open discectomy. 68 patients with highly migrated lumbar disc herniation had undergone discectomy. Thirty-five of them randomly received computerized tomography (CT) navigation percutaneous spinal endoscopy at the pain department (CT navigation percutaneous spinal endoscopy group), and 33 patients received open discectomy at the orthopedics department (open discectomy group). The Visual AnalogScale (VAS) score, Japanese Orthopaedic Association (JOA) score, and modified MacNab criteria were applied to evaluate the clinical situations pre- and post-operation. The serum concentrations of IL-6, TNF-alpha, creatine phosphokinase (CPK), and C-reactive protein (CRP) in the 2 groups were quantitatively measured. The postoperative VAS scores of the back and lower extremity were lower than those pre-operation in both groups, while the VAS score of backpain in the open discectomy group was significantly higher than that in the CT navigation percutaneous spinal endoscopy group at one week post-operation (P < 0.01). The postoperative JOA scores were significantly higher than those pre-operation in both groups. The serum concentrations of IL-6, TNF-alpha, CPK, and CRP in the open discectomy group were higher than those in the computerized tomography navigation percutaneous spinal endoscopy group postoperatively (P < 0.01).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The American Society of Pain and Neuroscience (ASPN) published clinical guidance for interventional treatments for low back pain (Sayed, 2022). The guideline states that discectomy procedures (such as percutaneous and endoscopic disc procedures) have favorable safety and efficacy profiles for the treatment of lumbar disc herniation with persistent radicular symptoms; however, it is stated that further research is needed to evaluate complications rates in order for these procedures to supplant classic open microdiscectomy. Recommendations specific to percutaneous endoscopic discectomy are summarized below.
Percutaneous Endoscopic Discectomy:
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| References: |
Ahn Y, Lee S-H, et al.(2004) Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: surgical technique, outcome, and prognostic factors of 43 consecutive cases. Spine 2004; 29:e326-e332. Automated percutaneous lumbar discectomy. Hayes, Inc 5/12/2006:1-15. Castro WH, Jerosch J, Hepp R, et al.(1992) Restriction of indication for automated percutaneous lumbar discectomy based on computed tomographic discography. Spine 1992; 17:1239-1243. Chatterjee S, Foy PM, Findlay GF.(1995) Report of a controlled clinical trial comparing automated percutaneous discectomy and microdiscectomy in the treatment of contained lumbar disc herniation. Spine 1995; 20:734-738. Choi KC, Lee JH, Kim JS, et al.(2015) Unsuccessful percutaneous endoscopic lumbar discectomy: a single-center experience of 10 228 cases. Neurosurgery. Apr 2015;76(4):372-381. 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